Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-291-4 | CAS number: 105-37-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-04-28 to 2016-06-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl propionate
- EC Number:
- 203-291-4
- EC Name:
- Ethyl propionate
- Cas Number:
- 105-37-3
- Molecular formula:
- C5H10O2
- IUPAC Name:
- ethyl propanoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Epi-200 kits purchased from MatTek Corporation (Bratislava, Slovakia), containing EpiDerm™ tissues on agarose.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ tissues (Epi-200 SIT kits, MatTek)
- Tissue batch number(s): Lot No.: 23339
- Delivery date: 19 January, 2016
- Date of initiation of testing: 19 January, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5 °C for 35 minutes, remaining period of treatment at room temperature on a sterile bench
- Temperature of post-treatment incubation (if applicable): 37 ± 1.5 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsing with DPBS at least 15 times, followed by submerging of inserts in DPBS at least 3 times, then additional rinsing with sterile DPBS (volume not stated)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3h
- Spectrophotometer: Versamax®Molecular Devices, Softmax Pro (version 4.7.1)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
Positive control: mean viability: 4.77%; relative standard deviation: 14.9%; range of viabilities: 4.00-5.90%.
-Absorption:
Positive control: mean absorption: 0.084; relative standard deviation: 16.6%; range of absorbance: 0.069-0.097
Negative control: mean absorption: 1.77; relative standard deviation: 8.55%, range of absorbance: 1.66-1.98
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Yes. Evaluation of colour interference: 30 µL of the test item mixed with 300 µL deionised water was incubated for 60 minutes at 37 ± 1.5 °C. Since the colour of the test item mixture did not change during the incubation period, the pre-experiment for colour interference was not continued.
Evaluation of direct reduction of MTT: 30 µL of the test item added to MTT (1 mg/ml). Incubated in the dark at 37 ± 1.5 °C for 60 minutes. Since the colour did not turn blue/purple, the test item was not considered to be a MTT reducer.
PREDICTION MODEL / DECISION CRITERIA
For the current test, an irritation potential of a test item is determined and classification is recommended if the mean relative tissue viability of three individual tissues is reduced to less than or equal to 50% of the negative control. The following in vitro results have been related to the following in vivo predictions:
Mean tissue viability =50% = irritant (I)
Mean tissue viability >50% = non-irritant (NI)
Acceptability of the Assay
Criterion 1 (negative control): The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD570 of the negative control tissues is > 0.8 and =2.8.
Criterion 2 (positive control): An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is at or below 20%.
Criterion 3 (standard deviation): The SD of 3 identical replicates should be < 18%.
OD values should not be below historically established boundaries. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL (47 µL/cm2 according to guideline) of the undiluted test item was dispensed directly atop the EpiDerm™ tissue and spread to match the surface of the tissue.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS (MatTek) was used as a negative control per tissue.
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL of a 5% SLS solution in deionised water (MatTek) was used as a positive control per tissue. - Duration of treatment / exposure:
- 60 minutes.
- Duration of post-treatment incubation (if applicable):
- 41 hours and 37 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 4.3
- Other effects / acceptance of results:
- - Direct-MTT reduction: test item did not reduce MTT
- Colour interference with MTT: test item did not change colour in the colour interference test
- After treatment with the negative control the absorbance values were well in the required range of the acceptability criterion of mean OD = 0.8 and = 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
- Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system; the mean relative absorbance value of the positive control was 4.3% compared to the negative control.
In vivo
- Irritant / corrosive response data:
- The test item is considered to possess an irritant potential.
Any other information on results incl. tables
Results after treatment with test substance and the controls (exposure interval of 60 minutes):
Dose Group | Tissue No.: | Absorbance 570 nm Well 1 |
Absorbance 570 nm Well 2 |
Absorbance 570 nm Well 3 |
Mean Absorbance of 3 Wells |
Mean Absorbance of 3 wells blank corrected |
Mean Absorbance of 3 Tissues after blank correction |
Relative Absorbance [%] Tissue 1,2,3 |
Relative Standard Deviation [%] |
Mean Relative Absorbance [% of Negative Control] |
Blank | 0.036 | 0.037 |
0.036 | 0.036 | 0.000 | |||||
Negative Control | 1 | 1.960 | 1.998 | 1.990 | 1.982 | 1.946 | 102.9 | |||
2 | 1.912 | 1.866 | 1.865 | 1.881 | 1.845 | 1.891 | 97.6 | 2.7 | 100.0 | |
3 | 1.935 | 1.916 | 1.903 | 1.918 | 1.881 | 99.5 |
|
|||
Positive Control |
1 |
0.113 |
0.113 |
0.119 |
0.115 |
0.079 |
|
4.2 |
|
|
|
2 |
0.120 |
0.119 |
0.122 |
0.120 |
0.084 |
0.081 |
4.4 |
3.3 |
4.3 |
|
3 |
0.117 |
0.116 |
0.116 |
0.116 |
0.080 |
|
4.2 |
|
|
Test Item |
1 |
0.108 |
0.115 |
0.117 |
0.113 |
0.077 |
|
4.1 |
|
|
|
2 |
0.112 |
0.112 |
0.118 |
0.114 |
0.078 |
0.081 |
4.1 |
8.6 |
4.3 |
|
3 |
0.124 |
0.126 |
0.128 |
0.126 |
0.089 |
|
4.7 |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- It can be stated that in this study and under the experimental conditions reported, the test substance is an irritant to skin according to UN GHS and EU CLP regulation. However, on their own these data are not sufficient to resolve between category 1 and 2.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test.
The test item passed the MTT- and the Colour Interference pre-tests. After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD³0.8 and = 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 4.3% thus ensuring the validity of the test system.
The relative standard deviations between the % variabilities of the test item, the positive and negative controls in the main test were below 9% (threshold of the "OECD Guideline for the Testing of Chemicals 439:In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: < 18%), thus ensuring the validity of the study.
Compared to the relative absorbance value of the negative controlthe mean relative absorbance value was reduced to 4.3% after exposure of the skin tissues to the test item. This value is below the threshold for irritancy of = 50%. Therefore, the test item is considered to possess an irritant potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.